How to Achieve P620 Compliance in Your Lab’s Packaging Process

1. medical packaging When shipping infectious substances, especially those classified as Category A under UN2814 or UN2900, the stakes rise considerably. The risks of leaks, exposure, or regulatory noncompliance are not abstract. They can mean contaminated shipments, potential exposure for couriers and lab staff, hefty fines, or even revocation of your shipping privileges. P620 compliance sits at the core of safely transporting these hazardous specimens. Yet, many laboratories and clinics underestimate the complexity of the requirements or rely on generic specimen shipping containers ill-suited for high-risk materials. This article draws on practical experience from the field: what works, what fails under pressure, and how to navigate the real-world trade-offs when selecting and validating packaging. We’ll clarify the regulatory landscape, walk through each layer of compliant packaging, and highlight the details that often matter most - not just for passing inspection, but for truly safe, reliable shipment. Where P620 Rules Apply - And Why They Matter P620 is the packaging instruction set out in both IATA Dangerous Goods Regulations and the UN Model Regulations. It applies specifically to Category A infectious substances: pathogens that can cause permanent disability or life-threatening disease in otherwise healthy humans or animals. Unlike Category B (which uses P650 packaging), Category A shipments must withstand far more rigorous testing. Most public health labs, clinical reference facilities, and some research organizations will ship Category A materials at least occasionally. Common examples include Ebola, SARS-CoV-2 viral cultures, or Bacillus anthracis (anthrax). If you’re moving such samples, there’s no shortcut: you must use P620 compliant packaging, not just any specimen transport system. The Regulatory Maze: IATA, DOT, UN3373, and P620 It’s easy to get lost in the web of codes: UN3373, UN2814, UN2900, P650, P620. Each refers to a distinct risk class and packaging protocol. For Category B (diagnostic specimens), UN3373 packaging and P650 instructions suffice. But Category A substances require UN2814 (infectious to humans) or UN2900 (infectious to animals only) labeling and full P620 packaging. The key differences between P650 and P620 aren’t subtle. While both require triple packaging - primary leakproof vessel, secondary leakproof container, and outer rigid packaging - P620 goes much further. It mandates that the entire assembly passes a battery of physical tests: a 9-meter drop onto a hard surface, puncture resistance from a steel rod, internal pressure tests at 95kPa, and temperature cycling from -40°C to +55°C. Most off-the-shelf specimen shipping kits for clinics or diagnostic labs are not certified at this level. Anatomy of a Compliant P620 Package Let’s break down each layer required for a fully compliant Category A shipment: Primary Receptacle This is where your infectious specimen is held. It must be leakproof and able to withstand pressure changes and temperature swings. For blood or body fluids, certified cryotubes or glass vials with threaded closures and O-ring gaskets are common. The key is tight sealing - a double-zip 95kPa specimen bag alone is insufficient as a primary vessel for Category A. Absorbent material must surround the primary vessel in sufficient quantity to absorb the full volume of liquid if it ruptures. Cotton pads or commercial absorbent pouches are typical. For solids (such as tissue samples), the absorbent material may not be strictly required but is strongly recommended for mixed shipments. Secondary Container This is a second leakproof barrier. In practice, this is often a rigid SafetyBag container or a certified rigid specimen container 95kPa rated for pressure. The secondary must be able to contain the entire contents if the primary fails and still pass the 95kPa internal pressure test for liquids.

2. All paperwork (like the shipper’s declaration) should ride outside this secondary - typically in a document pouch attached to the outer packaging - to avoid contamination if a leak occurs. Outer Packaging The final shell must be rigid enough to protect everything inside from the rigors of transport: drops, compression, puncture hazards, and temperature swings. UN-certified fiberboard boxes or molded plastic crates with tamper-evident seals are widely used in public health specimen transport kits. Here’s where many labs stumble: most “standard” diagnostic specimen shipping kits are only certified for UN3373 Category B and will fail the drop or puncture test required by P620. Always check that your outer container has the UN specification marking indicating compliance with Packing Group I (the highest level). Practical Realities: Sourcing Compliant Supplies Even the most thorough SOP falls apart without access to genuinely compliant materials. Sourcing from a reputable specimen transport supplier https://claude.ai/public/artifacts/e5a0a3c6-3746-40ab-8d79-840267b68c71 USA-based labs trust is essential. Not all “UN3373 packaging” or “biological substance Category B packaging” vendors offer genuine P620 kits. Look for clear documentation: test certificates from an accredited lab showing conformance with Packing Instruction 620, including drop, puncture, and pressure testing results. Ask about batch traceability - in an audit or incident investigation, you’ll need to prove exactly which lot numbers were used. Many labs keep both P650 compliant packaging for routine diagnostic work and a smaller stock of full P620 compliant packaging for higher-risk shipments. This approach balances cost and readiness but relies on strong training to avoid mix-ups. Training and Process Control: Where Most Mistakes Happen The technical requirements of P620 packaging are only half the battle. In practice, compliance depends as much on human factors: labeling accuracy, closure torque on primary vials, correct placement of absorbents, and unambiguous segregation of Category A versus Category B shipments. An anecdote from one clinical reference lab illustrates this well. After a staff turnover event, several new hires began using clinic specimen mailing kits intended only for UN3373 shipments when tasked with sending rare viral cultures classified as Category A. The error went unnoticed until an airline safety inspection flagged the package due to incorrect UN markings and lack of the infectious substance diamond label. To prevent such lapses: Maintain separate storage areas clearly labeled for P620 and P650 kits Require documented training before staff can package Category A specimens Use checklists at each shipment stage - especially at handoff points between lab and courier A well-designed workflow integrates regular spot checks and periodic drills simulating spill scenarios or regulatory audits. Technical Edge Cases: Dry Ice, Temperature Control, and Multiple Specimens Shipping with dry ice introduces further complexity. While dry ice itself is regulated as UN1845 Class 9 (Miscellaneous Dangerous Goods), its use within a P620 system means outer containers must also be compatible with extreme cold and allow venting of CO2 gas buildup. Some rigid specimen containers lose their 95kPa integrity below -20°C; always verify cold-chain compatibility in your test certificates before using these containers for frozen shipments. When shipping multiple primary vessels within one secondary (for example, sending several viral isolates together), ensure that each vial is individually wrapped to prevent breakage by contact during drops or vibration in transit.

3. Documentation Essentials Every P620 shipment requires meticulous paperwork: A Shipper’s Declaration for Dangerous Goods (often called “DG Dec”) completed by trained personnel Accurate UN2814 or UN2900 labeling on the outer container Emergency contact details accessible throughout transit Missing paperwork remains one of the most common causes for shipment rejection by carriers or regulators. Cost-Benefit Considerations P620 compliant packaging costs noticeably more than diagnostic specimen packaging suitable for UN3373 materials - often two to four times as much per kit. There’s no room to cut corners: using generic watertight secondary bags or non- rigid outer boxes exposes your lab to major liability. However, overbuying isn’t wise either. Kits have expiration dates (especially those containing integrated absorbents or adhesive seals), and design improvements render older stock obsolete over time. Labs with infrequent Category A shipments often partner with specialized specimen transport suppliers USA-based or keep just-in-time inventory via expedited ordering. Step-by-Step Walkthrough: Packing a Category A Shipment The following checklist distills the essentials into actionable steps: Confirm that your sample meets the definition of Category A (check pathogen lists or consult your biosafety officer). Select certified P620 compliant primary receptacles and place appropriate absorbent material around each. Seal primaries inside a 95kPa-rated rigid secondary container. Place the secondary in the UN-marked rigid outer box. Attach all required hazard labels (UN2814/2900 diamond, orientation arrows if liquid). Affix the shipper’s declaration and ensure documentation rides outside the secondary container. Verify everything with a peer check before handing off to courier. Mistakes most often occur at steps 2 (using an uncertified vial) and 5 (missing small label details). Innovations in Specimen Transport Solutions The past decade has seen improvements in both usability and safety for high-risk specimen shipping kits: Rigid containers now integrate pressure-relief mechanisms that maintain 95kPa performance while allowing CO2 venting for dry ice shipments Absorbent “socks” molded into secondary containers prevent sample pooling during leaks Tamper-evident seals now include QR codes linking directly to batch certification documents Bulk 95kPa transport bags are available for labs needing economical options for high-throughput applications without sacrificing performance Yet no system substitutes for careful attention at the benchtop level. Common Pitfalls and How Experienced Labs Avoid Them Labs that ship infectious substances regularly develop informal habits that can make all the difference: Double-checking the compatibility of primary vessel stoppers after every reorder Keeping a “bad kit” file of failed containers or rejected batches for future training Assigning dedicated staffers to oversee high-risk shipments rather than rotating duties Regularly reviewing accident reports from other institutions (many are published in biosafety bulletins) to update internal protocols These small steps reduce near-misses and help maintain a culture of vigilance around hazardous materials shipping. Final Thoughts: Building Resilience into Your Packaging Program

4. Achieving and maintaining P620 compliance requires more than checking boxes on a form. It demands ongoing investment in training and equipment - but also in institutional memory and process discipline. Regulations evolve as new pathogens emerge; so do packaging technologies and best practices. Labs that take the time to understand each layer of the packaging process - from sourcing certified double-zip 95kPa specimen bags to verifying the puncture resistance of every new outer box - are best positioned to ship hazardous specimens safely every time. Infectious substance shipping isn’t just about ticking off regulations; it’s about protecting people at every step in the chain. When every link is strong - from procurement through final delivery - your lab can confidently meet both legal mandates and its own duty of care to patients, colleagues, and the wider community.